Director, Regulatory Affairs

The Position:

Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will collaborate with cross-functional teams, providing your expertise to support the development, review, and approval of strategies and documents crucial for clinical trials and marketing authorizations. Reporting to the Vice President of Regulatory and Quality Science, you'll be at the forefront of regulatory success, working closely with internal and external stakeholders to ensure our projects meet regulatory standards and milestones. If you're ready to make an impact, we want to hear from you!

Your Impact:

• Provide regulatory leadership and guidance to project teams and working collaboratively with cross-functional team members, vendors and consultants to identify optimal and effective regulatory strategies for assigned projects
• Develop and implement regulatory strategies for clinical development programs in alignment with corporate objectives and regulatory requirements
• Offer regulatory considerations for the design, conduct, and interpretation of clinical trials
• Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks
• Stay informed of emerging regulatory trends, guidance documents, and best practices related to clinical development and regulatory affairs
• Prepare and lead teams through successful regulatory meetings and interactions
• Lead the authoring, review and editing of high-quality, compliant regulatory documents according to specified timelines and goals
• Provide insight and guidance on the implementation of current regulations and assess regulatory risk based on precedence
• Contribute to the development and maintenance of Regulatory Affairs Department working practices and procedures

As a Director, we also expect our leaders to demonstrate the following Leadership Competencies:

• Communication and Influence
  • Builds communication channels across Maze for sharing information
  • Influences Senior Management decisions through persuasive arguments
  • Respectfully addresses differing opinions leading to support of decision
• Teamwork and Collaboration
  • Champions partnerships and connections across Maze
  • Proactively addresses issues that could result in breakdown of team relationships
  • Spotlights team and individual contributions in public forums
• Execution and Results
  • Addresses gaps and leverages strengths to get best results
  • Maintains a steadying presence and clarifies priorities during change
  • Anticipates and removes barriers that put functional/corporate goals at risk
• Develop Others and Self
  • Removes barriers to staff development and empowers them to make their own decisions
  • Stays current on industry trends and keeps direct-reports prepared and responsive

Qualifications:

• Bachelor's degree required. Advanced degree in life sciences preferred.
• 10+ years or equivalent relevant experience in regulatory affairs
• Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs
• Experience and expertise in the preparation of IND/CTAs (required) and NDA/BLA/MAAs (desirable), as well as supportive amendments and supplements
• Proven ability to manage multiple projects, proactively identifying potential problems and to partner effectively and positively to solve issues
• Excellent organizational and communication skills, both written and verbal
• Well-prepared, proactive, and comfortable handling broad responsibilities in a fast-paced, small company environment

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission. 

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $218,00 to 267,000. Additionally, this position is eligible for an annual performance bonus.

Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.